DRY IT OUT ACNE SPOT TREATMENT- salicylic acid gel 
Pacifica Beauty, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dry It Out Acne Spot Treatment

Active ingredient Purpose

Salicylic Acid 2.0% Acne Medication

Use

For the treatment of acne.

Warnings

For external use only. Flammable: Keep away from fire or flame. When using this product: skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

When using this product: skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity test for a new user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive ingredients:

Aqua, Alcohol Denat., Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Aloe Barbadensis Leaf Juice*, Hydroxyethylcellulose, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract*, Spiraea Ulmaria (Meadowsweet) Extract, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Lens Esculenta (Lentil) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Camellia Sinensis (White Tea) Leaf Extract*, Arnica Montana Flower Extract*, Dipotassium Glycyrrhizate, Parfum**. *certified organic **our scent blend with natural and/or essential oils

Questions or comments?

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Pacifica Beauty LLC Portland, Oregon

Dry It Out Acne Spot Treatment Label

Dry It Out Acne Spot Treatment Label

DRY IT OUT ACNE SPOT TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ALCOHOL (UNII: 3K9958V90M)  
HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
SAGE OIL (UNII: U27K0H1H2O)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
WATER (UNII: 059QF0KO0R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61197-122-0029 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00602/09/2023
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Sun Deep Inc.189788201manufacture(61197-122)

Revised: 2/2023
Document Id: f44c0be7-9566-0068-e053-2a95a90a9705
Set id: f44c0be7-9565-0068-e053-2a95a90a9705
Version: 1
Effective Time: 20230209
 
Pacifica Beauty, LLC